Transcranial Magnetic Stimulation to Measure Cortical Excitability in Dravet Syndrome
NCT ID: NCT04614506
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
6 participants
OBSERVATIONAL
2020-11-02
2022-12-31
Brief Summary
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As a pilot study assessing for feasibility, the investigators aim to test whether alterations in cortical excitatory:inhibitory ratio can be reliably recorded. The investigators will utilize transcranial magnetic stimulation (TMS) metrics of cortical excitatory and inhibitory tone as an initial step towards translating findings from rodent genetic models of DS into disease-specific biomarkers and offer future measures of therapeutic target engagement in this patient population.
Participants will complete two visits, each consisting of a TMS session and an EEG session. Visits will be scheduled 4-8 weeks apart.
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Detailed Description
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Mechanistically, the features of the DS phenotype are attributable to a loss of cortical inhibition. TMS is a non-invasive form of focal cortical stimulation in which an external powerful magnet induces an electrical field intracranially over the stimulated region that is used to interrogate or modulate states of cortical excitation or inhibition.
Accordingly, the investigators propose to test whether metrics of cortical excitability and inhibition can be obtained by transcranial magnetic stimulation (TMS) and EEG in patients with DS.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subject with DS
Participants will complete two visits spaced out by 4 - 8 weeks to undergo neurophysiological assessments (Electroencephalogram \[EEG\], and Transcranial magnetic stimulation \[TMS\]).
Transcranial Magnetic Stimulation (TMS)
Transcranial magnetic stimulation (TMS) is a method for noninvasive electrical cortical stimulation, where small intracranial currents are generated by a powerful, fluctuating, extracranial magnetic field. TMS is unique in its capacity for experimental, diagnostic, and therapeutic utility. Single pulse (spTMS) and paired-pulse TMS (ppTMS) have been used extensively to study, measure, and modulate cortical excitability and plasticity.
Electroencephalogram (EEG)
These will be an ambulatory EEG recordings that span 24 hours and done without sedation. Recordings will be performed using electrode locations specified by the international 10-20 system for standard clinical practice.
Interventions
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Transcranial Magnetic Stimulation (TMS)
Transcranial magnetic stimulation (TMS) is a method for noninvasive electrical cortical stimulation, where small intracranial currents are generated by a powerful, fluctuating, extracranial magnetic field. TMS is unique in its capacity for experimental, diagnostic, and therapeutic utility. Single pulse (spTMS) and paired-pulse TMS (ppTMS) have been used extensively to study, measure, and modulate cortical excitability and plasticity.
Electroencephalogram (EEG)
These will be an ambulatory EEG recordings that span 24 hours and done without sedation. Recordings will be performed using electrode locations specified by the international 10-20 system for standard clinical practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to obtain informed consent with the participant or legally authorized representative
* DS confirmed by pathogenic variant in SCN1A gene
* Medical history consistent with clinical phenotype of DS
Exclusion Criteria
* Current or planned participation in a clinical drug or device trial.
* Previous participation in a gene therapy or gene editing trial
* Allergy to adhesives used for surface EMG electrodes
* Contraindications to TMS (e.g. implanted devices for which there is no TMS safety data)
6 Months
30 Years
ALL
No
Sponsors
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Encoded Therapeutics
INDUSTRY
Boston Children's Hospital
OTHER
Responsible Party
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Alexander Rotenberg
Associate, Department of Neurology; Director, Neuromodulation Program; Associate Professor of Neurology, Harvard Medical School
Principal Investigators
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Alexander Rotenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-P00034206
Identifier Type: -
Identifier Source: org_study_id
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